Brigatinib vs crizotinib in the phase 3 ALTA-1L trial: Updated results
dc.contributor.author | Griesinger, F. | |
dc.contributor.author | Kim, H. R. | |
dc.contributor.author | Ahn, M. J. | |
dc.contributor.author | Yang, J. C. | |
dc.contributor.author | Han, J. Y. | |
dc.contributor.author | Hochmair, M. | |
dc.contributor.author | Lee, K. H. | |
dc.contributor.author | Delmonte, A. | |
dc.contributor.author | Campelo, M. R. G. | |
dc.contributor.author | Kim, D. W. | |
dc.contributor.author | Felip, E. | |
dc.contributor.author | Califano, Raffaele | |
dc.contributor.author | Spira, A. | |
dc.contributor.author | Gettinger, S. | |
dc.contributor.author | Tiseo, M. | |
dc.contributor.author | Lin, H. | |
dc.contributor.author | Liu, Y. | |
dc.contributor.author | Zhang, P. | |
dc.contributor.author | Popat, S. | |
dc.contributor.author | Camidge, D. R. | |
dc.date.accessioned | 2020-11-16T07:49:09Z | |
dc.date.available | 2020-11-16T07:49:09Z | |
dc.date.issued | 2020 | en |
dc.identifier.citation | Griesinger F, Kim HR, Ahn MJ, Yang JC, Han JY, Hochmair M, et al. Brigatinib vs crizotinib in the phase 3 ALTA-1L trial: Updated results. Oncology Research and Treatment. 2020;43(SUPPL 4):142- | en |
dc.identifier.uri | http://hdl.handle.net/10541/623385 | |
dc.description.abstract | Introduction: We report results of the second interim analysis from ALTA-1L (NCT02737501), planned at 75% of 198 expected events. Methods: Patients with anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI)-naive advanced ALK-positive non-small cell lung cancer (ALK+ NSCLC) were enrolled. One prior chemotherapy for advanced NSCLC and asymptomatic brain metastases were allowed. Patients were randomized 1:1 to brigatinib 180 mg qd with 7-day lead-in at 90 mg or crizotinib 250 mg BID. The primary endpoint was blinded independent review committee (BIRC)-assessed progression-free survival (PFS; RECIST v1.1). Secondary endpoints (by BIRC) included confirmed objective response rate (ORR) and intracranial ORR (iORR), as well as intracranial PFS (iPFS). Results: 275 patients were randomized (brigatinib/crizotinib, n=137/138); median age was 58/60 years. In total, 26%/27% received prior chemotherapy; 29%/30% had baseline brain metastases. As of 28 June 2019, median follow-up for brigatinib/crizotinib was 24.9/15.2 mo, with 150 PFS events. BIRC-assessed PFS HR was 0.49 (95% CI 0.35-0.68; log-rank P< 0.0001); median PFS (mPFS) was 24.0 mo (18.5-not estimable [NE]) for brigatinib vs 11.0 mo (9.2-12.9) for crizotinib. Investigator-assessed PFS HR was 0.43 (0.31-0.61; mPFS 29.4 vs 9.2 mo). Overall survival was immature (events: 33/37, brigatinib/crizotinib). Early benefit for brigatinib was observed in patients with baseline brain metastases; 6 mo PFS by BIRC was 89.0% for brigatinib and 47.5% for crizotinib. Independent of prior chemotherapy, the subgroup of patients with baseline brain metastases consistently benefited more than those without baseline brain metastases. Table shows additional efficacy data. Conclusions: Brigatinib showed superior PFS vs crizotinib in all patient subgroups with ALK TKI-naive ALK+ NSCLC. Based on these data, brigatinib has been approved by the EMA in 2020 for first-line therapy. | en |
dc.language.iso | en | en |
dc.title | Brigatinib vs crizotinib in the phase 3 ALTA-1L trial: Updated results | en |
dc.type | Meetings and Proceedings | en |
dc.contributor.department | Carl von Ossietzky Univ Oldenburg, Pius Hosp Oldenburg, Oldenburg, Germany | en |
dc.identifier.journal | Oncology Research and Treatment | en |
dc.description.note | en] |